Effects of Vitamin D Supplementation During Pregnancy on Clinical Outcomes and Immune Function
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
400 IU vitamin D3
2,000 IU Vitamin D3
Sponsored by
About this trial
This is an interventional basic science trial for Vitamin D Deficiency focused on measuring pregnancy, immune function
Eligibility Criteria
Inclusion Criteria:
- Pregnant women
- Less than 20 weeks gestation
- Over 18 years of age
- Able to swallow nutritional supplements
Exclusion Criteria:
- Use of medications known to affect vitamin D metabolism
- Diagnosis of type 1 diabetes
- History of thyroid, renal, or liver disease
- Problems with digestion or absorption
Sites / Locations
- USDA-Western Human Nutrition Research Center
- UC Davis Medical Center Obstetrics & Gynecology
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
400 IU Vitamin D3
2,000 IU Vitamin D3
Arm Description
Women in this study arm receive 400 IU of vitamin D3 per day, or what is in a standard prenatal multivitamin. They also receive a placebo study supplement.
Women in this arm receive 2,000 IU vitamin D per day: 400 IU from a standard prenatal multivitamin plus an additional 1,600 IU vitamin D3 in the study supplement.
Outcomes
Primary Outcome Measures
Change in T-cell cytokine expression
Inflammatory and regulatory cytokines will be measured in cultured T-cells by flow cytometry.
Secondary Outcome Measures
Change in Vitamin D status
Serum 25-OH vitamin D and 1, 25 (OH)2 Vitamin D
Change in innate immune function
Monocyte and NK cell cytokine expression and response to stimulation with Toll-like Receptor agonists.
Change in blood pressure
Blood pressure will be measured using standard techniques.
Full Information
NCT ID
NCT01417351
First Posted
August 12, 2011
Last Updated
July 22, 2013
Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT01417351
Brief Title
Effects of Vitamin D Supplementation During Pregnancy on Clinical Outcomes and Immune Function
Official Title
Assessment of Inflammatory Markers and Pregnancy Outcomes in Vitamin D-Supplemented Women at Risk of Vitamin D Deficiency: A Double-Blind, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers at the USDA Western Human Nutrition Research Center and clinicians at UC Davis Medical Center are currently conducting a study on the effects of vitamin D supplementation during pregnancy on maternal health and immune function. The investigators believe that vitamin D supplementation at levels greater than the current recommendation is beneficial for maternal health during pregnancy. In particular, there is evidence that vitamin D deficiency during pregnancy puts women at greater risk for diseases like pre-eclampsia, which may be due to an imbalance in immune function at the placenta. This randomized, double-blind study is designed to test this hypothesis. Pregnant women who participate in the study receive either 400 IU or 2,000 IU of vitamin D per day for the duration of their pregnancy. The investigators will collect blood at three time points during pregnancy (16-20 weeks, 26-28 weeks, 36 weeks gestation) for analysis of immune function and vitamin D status. The investigators are also collecting data on clinical parameters, such as blood pressure and glucose tolerance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
pregnancy, immune function
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
400 IU Vitamin D3
Arm Type
Placebo Comparator
Arm Description
Women in this study arm receive 400 IU of vitamin D3 per day, or what is in a standard prenatal multivitamin. They also receive a placebo study supplement.
Arm Title
2,000 IU Vitamin D3
Arm Type
Experimental
Arm Description
Women in this arm receive 2,000 IU vitamin D per day: 400 IU from a standard prenatal multivitamin plus an additional 1,600 IU vitamin D3 in the study supplement.
Intervention Type
Dietary Supplement
Intervention Name(s)
400 IU vitamin D3
Intervention Description
Women in this study arm receive 400 IU of vitamin D3 per day, or what is in a standard prenatal multivitamin. They also receive a placebo study supplement.
Intervention Type
Dietary Supplement
Intervention Name(s)
2,000 IU Vitamin D3
Intervention Description
Women in this arm receive 2,000 IU vitamin D per day: 400 IU from a standard prenatal multivitamin plus an additional 1,600 IU vitamin D3 in the study supplement.
Primary Outcome Measure Information:
Title
Change in T-cell cytokine expression
Description
Inflammatory and regulatory cytokines will be measured in cultured T-cells by flow cytometry.
Time Frame
16-20 wks, 26-28 wks, and 36 wks gestation
Secondary Outcome Measure Information:
Title
Change in Vitamin D status
Description
Serum 25-OH vitamin D and 1, 25 (OH)2 Vitamin D
Time Frame
16-20 wks, 26-28 wks, 36 wks gestation
Title
Change in innate immune function
Description
Monocyte and NK cell cytokine expression and response to stimulation with Toll-like Receptor agonists.
Time Frame
16-20 wks, 26-28 wks, 36 wks gestation
Title
Change in blood pressure
Description
Blood pressure will be measured using standard techniques.
Time Frame
16-20 wks, 26-28 wks, 36 wks gestation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women
Less than 20 weeks gestation
Over 18 years of age
Able to swallow nutritional supplements
Exclusion Criteria:
Use of medications known to affect vitamin D metabolism
Diagnosis of type 1 diabetes
History of thyroid, renal, or liver disease
Problems with digestion or absorption
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles B Stephensen, PhD
Organizational Affiliation
USDA, ARS, Western Human Nutrition Research Center
Official's Role
Study Director
Facility Information:
Facility Name
USDA-Western Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
UC Davis Medical Center Obstetrics & Gynecology
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27655755
Citation
Zerofsky MS, Jacoby BN, Pedersen TL, Stephensen CB. Daily Cholecalciferol Supplementation during Pregnancy Alters Markers of Regulatory Immunity, Inflammation, and Clinical Outcomes in a Randomized Controlled Trial. J Nutr. 2016 Nov;146(11):2388-2397. doi: 10.3945/jn.116.231480. Epub 2016 Sep 21.
Results Reference
derived
Learn more about this trial
Effects of Vitamin D Supplementation During Pregnancy on Clinical Outcomes and Immune Function
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